Bronchitol
- Product NDC
- 10122-212
- 11-digit product format
- 101220212
- Labeler code
- 10122
- Product ID
- 10122-212_379b5638-1dd3-4383-927f-2c1e04da8e33
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- mannitol
- Dosage form
- CAPSULE
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Chiesi USA, Inc.
- Application
- NDA202049
- Marketing category
- NDA
- Marketing start
- 2021-02-01
- Marketing end
- 0000-00-00
- Substance
- MANNITOL
- Active strength
- 40 mg/1
- Pharmacologic classes
- Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10122-212 | BRONCHITOL (MANNITOL) CAPSULE [CHIESI USA, INC.] | 5 | Legacy NDC | 20240123_454f092e-dcd0-47bd-a521-b07400403dad.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 10122-212-02 | 10122021202 | 1 BLISTER PACK in 1 CARTON (10122-212-02) > 10 CAPSULE in 1 BLISTER PACK (10122-212-01) | 1 blister pack | 2021-02-01 | 0000-00-00 | Yes | No | Current |
| 10122-212-04 | 10122021204 | 1 BLISTER PACK in 1 CARTON (10122-212-04) > 10 CAPSULE in 1 BLISTER PACK (10122-212-01) | 1 blister pack | 2021-02-01 | 0000-00-00 | No | No | Current |
| 10122-212-14 | 10122021214 | 14 BLISTER PACK in 1 CARTON (10122-212-14) > 10 CAPSULE in 1 BLISTER PACK (10122-212-01) | 14 blister pack | 2021-02-01 | 0000-00-00 | No | No | Current |
| 10122-212-56 | 10122021256 | 4 CARTON in 1 BOX (10122-212-56) > 14 BLISTER PACK in 1 CARTON (10122-212-14) > 10 CAPSULE in 1 BLISTER PACK (10122-212-01) | 4 carton | 2021-02-01 | 0000-00-00 | No | No | Current |